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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lithotriptor, Extracorporeal Shock-Wave, Urological
510(k) Number K010900
Device Name STS-T LITHOTRIPTER, MODEL STS-T
Applicant
Medstone Intl., Inc.
100 Columbia, Suite 100
Aliso Viejo,  CA  92656
Applicant Contact RONALD BERGESON
Correspondent
Medstone Intl., Inc.
100 Columbia, Suite 100
Aliso Viejo,  CA  92656
Correspondent Contact RONALD BERGESON
Regulation Number876.5990
Classification Product Code
LNS  
Date Received03/26/2001
Decision Date 04/05/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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